PHYTONADIONE Drug Patent Profile

Which patents cover Phytonadione, and what generic alternatives are available?

Phytonadione is a drug marketed by Cipla, Dr Reddys, Gland Pharma Ltd, Glaxosmithkline, Intl Medication, Agnitio, Amneal Pharms Co, Hikma, Sciegen Pharms Inc, and Zydus Lifesciences. and is included in twelve NDAs.

The generic ingredient in PHYTONADIONE is phytonadione. There are ten drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phytonadione

A generic version of PHYTONADIONE was approved as phytonadione by AMNEAL PHARMS CO on May 11^th, 2018.

Summary for PHYTONADIONE

US Patents:	0
Applicants:	10
NDAs:	12
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	7
Patent Applications:	3,080
Drug Prices:	Drug price information for PHYTONADIONE
What excipients (inactive ingredients) are in PHYTONADIONE?	PHYTONADIONE excipients list
DailyMed Link:	PHYTONADIONE at DailyMed

See drug prices for PHYTONADIONE

Recent Clinical Trials for PHYTONADIONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Australasian Kidney Trials Network	Phase 3
Waitemata District Health Board	Phase 3
Salford Royal NHS Foundation Trust	Phase 3

See all PHYTONADIONE clinical trials

Pharmacology for PHYTONADIONE

Drug Class	Vitamin K Warfarin Reversal Agent
Physiological Effect	Increased Prothrombin Activity Reversed Anticoagulation Activity

US Patents and Regulatory Information for PHYTONADIONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	084060-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Amneal Pharms Co	PHYTONADIONE	phytonadione	TABLET;ORAL	209373-001	May 11, 2018	AB	RX	No	No
Cipla	PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	212424-001	Apr 22, 2022		DISCN	No	No
Cipla	PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	212424-002	Apr 22, 2022		DISCN	No	No
Sciegen Pharms Inc	PHYTONADIONE	phytonadione	TABLET;ORAL	213329-001	Jul 28, 2023	AB	RX	No	No
Cipla	PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	214596-001	Apr 22, 2022		RX	No	Yes
Gland Pharma Ltd	PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	217386-001	Dec 10, 2024	AB1	RX	No	No

Market Dynamics and Financial Trajectory for Phytonadione

Introduction

Phytonadione, also known as Vitamin K1, is a crucial vitamin used in various medical applications, including the treatment of bleeding disorders and as an antidote for warfarin overdose. Here, we will delve into the market dynamics and financial trajectory of phytonadione, highlighting key trends, drivers, and challenges.

Market Size and Growth

The vitamin K market, which includes phytonadione, is experiencing significant growth. The global vitamin K market was valued at USD 918.94 million in 2023 and is projected to reach USD 2,126.08 million by 2033, growing at a CAGR of 8.75% from 2024 to 2033[1].

Segments and Applications

Phytonadione is used in several segments, including pharmaceuticals and nutritional supplements. Here are some key applications:

Pharmaceuticals

Phytonadione is widely used in the pharmaceutical industry for treating bleeding disorders, such as hemophilia, and as an antidote for anticoagulant overdose. The anticoagulants market, which is closely related, is estimated to reach $74.3 billion by 2030, growing at a CAGR of 8.7% from 2022 to 2030[3].

Nutritional Supplements

Phytonadione is also part of the broader vitamin K market, which includes vitamin K2. The global vitamin K2 market was valued at USD 421.1 million in 2023 and is projected to grow at a CAGR of 10.8% from 2024 to 2030, driven by increasing consumer awareness of its health benefits[4].

Financial Performance

Amphastar Pharmaceuticals, a key player in the production and distribution of phytonadione, provides insights into the financial trajectory of this drug.

Revenue Trends

In the second quarter of 2022, Amphastar Pharmaceuticals reported net revenues of $123.5 million, with phytonadione sales contributing $13.381 million, a 28% increase from the previous year[5].

However, in the second quarter of 2024, the sales of phytonadione decreased by 42% to $10.3 million, indicating a recent decline in revenue from this product[2].

Gross Margin and Cost of Revenues

The gross margin for Amphastar Pharmaceuticals has been improving, driven by the sales of higher-margin products. However, the decline in phytonadione sales has impacted the overall revenue and gross margin. For instance, in Q2 2024, the gross profit margin improved to 52.2% from 49.9% in Q2 2023, but this was largely due to the performance of other products like BAQSIMI and epinephrine[2].

Drivers and Challenges

Drivers

• Increasing Prevalence of Chronic Disorders: The growing prevalence of chronic disorders, such as cardiovascular diseases and bleeding disorders, drives the demand for phytonadione[1].
• Aging Population: An aging population increases the demand for health supplements and pharmaceuticals, including phytonadione[4].
• Technological Advancements: Improvements in manufacturing technology enhance the quality and availability of phytonadione products[4].

Challenges

• Market Competition: The vitamin K market is competitive, with multiple players offering similar products. This competition can lead to price pressures and reduced market share[1].
• Regulatory Changes: Changes in regulatory approvals and guidelines can impact the sales and distribution of phytonadione. For example, the discontinuation of API suppliers can lead to revenue losses, as seen with Amphastar Pharmaceuticals[2].
• Consumer Preferences: Shifts in consumer preferences towards natural and plant-based products can affect the demand for synthetic forms of phytonadione[4].

Regional Market Dynamics

North America

The U.S. vitamin K market, which includes phytonadione, is significant and growing. The U.S. market size was USD 250.87 million in 2023 and is anticipated to reach USD 580.42 million by 2033, growing at a CAGR of 8.75% from 2024 to 2033[1].

Asia-Pacific

The Asia-Pacific region, particularly countries like Japan and South Korea, shows significant adoption of vitamin K2 products, which can influence the demand for phytonadione as well. The region's growing middle-class population with greater disposable incomes drives the demand for nutritional supplements[4].

Key Takeaways

• Growing Market: The global vitamin K market, including phytonadione, is expected to grow significantly over the next decade.
• Financial Performance: While phytonadione sales have seen recent declines, the overall market trends indicate potential for recovery and growth.
• Drivers and Challenges: Increasing prevalence of chronic disorders, technological advancements, and an aging population drive the market, but regulatory changes and market competition pose challenges.
• Regional Dynamics: North America and the Asia-Pacific region are key markets with significant growth potential.

FAQs

1. What is the projected growth rate of the global vitamin K market? The global vitamin K market is projected to grow at a CAGR of 8.75% from 2024 to 2033[1].

2. What are the main applications of phytonadione? Phytonadione is used in treating bleeding disorders and as an antidote for anticoagulant overdose, as well as in nutritional supplements[1][3].

3. Why did phytonadione sales decline in Q2 2024 for Amphastar Pharmaceuticals? The decline in phytonadione sales in Q2 2024 for Amphastar Pharmaceuticals was part of a broader trend of declining sales for certain products, despite overall revenue growth driven by other products[2].

4. How does the aging population impact the demand for phytonadione? An aging population increases the demand for health supplements and pharmaceuticals, including phytonadione, due to the higher incidence of chronic disorders in older populations[4].

5. What are the key regions driving the growth of the vitamin K market? North America and the Asia-Pacific region are key drivers of the vitamin K market growth, driven by increasing awareness of health benefits and demographic factors[1][4].

Sources

1. Precedence Research - Vitamin K Market Size, Share, and Trends 2024 to 2033
2. Stock Titan - Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended June 30, 2024
3. Globe Newswire - Global Anticoagulants Market to Reach $74.3 Billion by 2030
4. Grand View Research - Vitamin K2 Market Size, Share And Growth Report, 2030
5. Amphastar Pharmaceuticals - Financial Results for the Three Months Ended June 30, 2022